Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in November

Upcoming Events: Task Force is Holding its Second Public Meeting on Transparency in November

The next public meeting on transparency will be held Tuesday, November 3, 2009. The task force plans to use a discussion group format to receive detailed and in-depth comments on three specific issues related to transparency at FDA. The topics to be covered are: (1) early communication about emerging safety issues concerning FDA-regulated products, (2) disclosure of information about product applications that are abandoned (i.e., no work is being done or will be undertaken to have the application approved) or withdrawn by the applicant before approval, and (3) communication of agency decisions about pending product applications.

For each topic, a panel will discuss a case study about the topic and answer questions that may be posed by task force members. Audience members will also have an opportunity to comment and ask questions following each discussion group.

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Ed Silverman’s Pharmalot
Full disclosure lacking ‐ Apotex says the FDA issued an import alert about its products, BUT doesn’t mention which ones http://bit.ly/Tg3Lp8:07 AM Sep 15th from bit.ly
Would it be possible for the FDA to provide – post- a list of the reported 40 Apotex generic drugs from their North York and Etobicoke facilities that have been put on FDA Import Alert?
Are these drugs still in distribution and dispense channels? If so, which ones and how much supply?
Are these APO drugs still available to patients who may order their medicines from the Internet? Isn’t this the time of year when many Medicare patients hit the ‘donut hole’ and might order their medicine from the Internet?

Here’s a great suggestion for providing important and helpful information to consumers. Place the MedWatch 3500A forms on line for all the public to see concerning drugs. You already provide this information for medical devices. Consumers and Doctors need to know about the MedWatchs that are being filed concerning FDA regulated drugs. The system now is in ascii which is outdated and cumbersome. This data is NOT helpful to consumers and physicians.

The FDA is a government entity that no longer can handle the job of overseeing the food supply and the drugs that are supplied and created for America’s consumption.The transparency will need to start with governmental change in regards to how drugs are followed once approved.We all assume that drugs are deemed safe if they make it to market,that is not true.In many ways the approval of a drug should go further than the clinical trial,the follow up on the success and safety profile can only be determined once it goes out to the masses ,population response is very telling.The FDA must change policy in drug approval to be able to be successful with it’s transparency efforts.We have found that when a drug is suspect in having postmarketing problems,the FDA makes a vague announcement and communicates these problems on a very small scale.We need transparency and better communication of serious adverse event reports to protect the public from the unlikely yet sad events that can occur to the illinformed consumer.Kate Miller